LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma

NCT03287947 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: LCI-GI-APX-NIN-00100021617
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to evaluate the disease control rate of nintedanib in subjects with metastatic appendiceal cancer for whom initial fluoropyrimidine-based chemotherapy has failed. Based on previous studies, the anticancer activity of nintedanib in lung and ovarian cancer trials, along with the similarities between appendiceal and colorectal cancer and potentially ovarian cancer, warrant additional investigation for the optimal treatment of metastatic appendiceal carcinomas.

Conditions

Appendix Cancer

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate

  The disease control rate is the proportion of those subjects with complete response, partial response, or stable disease, as defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per RECIST 1.1 criteria for target lesions assessed by radiologic evaluation of CT and tumor measurements: Complete Response (CR), Disappearance of all target and non-target lesions, any pathological lymph nodes reduced in short axis to \<10 mm; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor PD; Disease Control Rate (DCR) = CR + PR + SD.

  From first dose of study drug to date of progression as determined by RECIST 1.1, assessed up to 7.5 months.

Secondary Outcomes (3)

• Overall Survival

  From date of first dose of study treatment to the date of death from any cause, assessed up to 14.5 months.

• Progression-free Survival

  From date of first dose of study treatment to the date of progressive disease or death from any cause, whichever occurred first, assessed up to 7.5 months.

• Treatment Administration of Nintedanib, as Measured by Average Daily Dose of Nintedanib.

  From the first dose of study drug to the last dose, assessed up to 7.5 months.

Study Arms (1)

A

EXPERIMENTAL

Nintedanib

Drug: nintedanib

Interventions

nintedanib DRUG

Oral nintedanib, taken twice daily

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria:
• Age at least 18 years old
• Histologically confirmed appendiceal carcinoma stage IV
• Failure of initial fluoropyrimidine -based chemotherapy. Failure is defined as progression on or within 6 months of last day of therapy or intolerance of initial fluoropyrimidine-based chemotherapy.
• Life expectancy at least 3 months
• ECOG performance status score 0-2
• Presence of measurable and/or evaluable, non-measurable disease according to RECIST 1.1 criteria
• Written informed consent signed and dated by subject or Legally Authorized Representative (LAR) prior to admission to the study in accordance with ICH-GCP guidelines and to the local legislation.

You may not qualify if:

• Subjects must not meet any of the following criteria.
• Prior treatment with nintedanib or any other VEGFR inhibitor
• Known hypersensitivity to peanut or soya or to contrast media. History of hypersensitivity to contrast media is allowed if the subject is able to tolerate contrast media with pre-medication.
• Chemo-, hormone-, radio-(except for brain and extremities) or immunotherapy, or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug.
• Radiotherapy to any target lesion within the past 3 months prior to baseline imaging when that target lesion is the only target lesion identified on baseline imaging, unless it has subsequently grown.
• Persistence of clinically relevant therapy related toxicity from previous chemo and/or radiotherapy as determined by the investigator.
• Active brain metastases (e.g. stable for \<4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month) or leptomeningeal disease.
• Radiographic evidence of cavitary or necrotic tumors.
• Tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels.
• Anti-neoplastic treatment for appendiceal cancer, with other investigational drugs or treatment in another clinical trial within 30 days before start of study treatment.
• Therapeutic anticoagulation with drugs requiring INR monitoring (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid less than or equal to 325mg per day).
• Major injuries and/or surgery within the past 4 weeks prior to start of study treatment, incomplete wound healing or planned surgery during the on-treatment study period.
• History of clinically significant hemorrhagic or thromboembolic event in the past 6 months prior to consent.
• Known inherited predisposition to bleeding or thrombosis.
• Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction, congestive heart failure \> NYHA II, serious cardiac arrhythmia, pericardial effusion) within the past 12 months prior to start of study treatment.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Appendiceal Neoplasms

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases

Results Point of Contact

• Title: Danielle M Boselli
• Organization: Atrium Health/Levine Cancer Institute, Department of Cancer Biostatistics

Danielle.Boselli@AtriumHealth.org

12017903385

Study Officials

• Jimmy J Hwang, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm phase 2 study.

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: September 19, 2017
• Study Start: November 10, 2017
• Primary Completion: September 3, 2019
• Study Completion: October 27, 2019
• Last Updated: August 9, 2022
• Results First Posted: June 16, 2021

Record last verified: 2022-01

Locations

US (1)